USPTO Patents Application 10726066

United States Patent and Trademark Office

UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450

Alexandria, Virginia 22313-1450
www.uspto.gov

APPLICATION NO.

FILING DATE

FIRST NAMED INVENTOR

ATTORNEY DOCKET NO.

CONFIRMATION NO.

10/726,066

12/02/2003

2101 7590 08/25/2006

BROMBERG & SUNSTEIN LLP
125 SUMMER STREET
BOSTON, MA 02110-1618

Martin ZimmerJing

1941/172

2565

EXAMINER

KOHARSKJ, CHRISTOPHER

ART UNIT

PAPER NUMBER

3763

DATE MAILED: 08/25/2006

Please find below and/or attached an Office communication concerning this application or proceeding.

PTO-90C (Rev. 10/03)

. M * ,

Office Action Summary

Application No.

10/726,066

Applicant(s)

ZIMMERLING ET AL

Examiner

Christopher D. Koharski

Art Unit

3763

- The MAILING DATE of this communication appears on the cover sheet with the correspondence address -
Period for Reply

A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) OR THIRTY (30) DAYS,
WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.

- Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
after SIX (6) MONTHS from the mailing date of this communication.

- If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.

- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
earned patent term adjustment. See 37 CFR 1 .704(b).

Status

1 )^ Responsive to communication(s) filed on 19 May 2006 .
2a)K This action is FINAL. 2b)Q This action is non-final.

3) Q Since this application is in condition for allowance except for formal matters, prosecution as to the merits is

closed in accordance with the practice under Ex parte Quayle, 1935 CD. 1 1 , 453 O.G. 213.

Disposition of Claims

4) ^] Claim(s) 1 -4, 6-32 and 34 is/are pending in the application.

4a) Of the above claim(s) 7,8, 18, 19,23-25,27,28,31 and 32 is/are withdrawn from consideration.

5) Q Claim(s) is/are allowed.

6) S Claim(s) 1-4,6,9-17, 20-22,26,29,30 'and 34 is/are rejected.

7) D Claim(s) is/are objected to.

8) Q Claim(s) are subject to restriction and/or election requirement.

Application Papers

9) D The specification is objected to by the Examiner.

10)D The drawing(s) filed on is/are: a)Q accepted or b)D objected to by the Examiner.

Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1 .85(a).

Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
11 )□ The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.

Priority under 35 U.S.C. § 119

12)D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 1 19(a)-(d) or (f).
a)D All b)D Some * c)D None of:

1 .□ Certified copies of the priority documents have been received.

2. D Certified copies of the priority documents have been received in Application No. .

3. D Copies of the certified copies of the priority documents have been received in this National Stage

application from the International Bureau (PCT Rule 17.2(a)).
* See the attached detailed Office action for a list of the certified copies not received.

Attachment(s)

1) M Notice of References Cited (PTO-892)

2) □ Notice of Draftsperson's Patent Drawing Review (PTO-948)

3) □ Information Disclosure Statement(s) (PTO-1449 or PTO/SB/08)

Paper No(s)/Mail Date .

4) 0 Interview Summary (PTO-41 3)

Paper No(s)/Mail Date. .

5) □ Notice of Informal Patent Application (PTO-152)

6) □ Other: .

U.S. Patent and Trademark Office
PTOL-326 (Rev. 7-05)

Office Action Summary

Part of Paper No./Mail Date 08212006

Application/Control Number: 10/726,066 Page 2

Art Unit: 3763

DETAILED ACTION
Response to Amendment

Examiner acknowledges amended claims 1, 4, 21, 29 and new claim 34.
Currently claims 1-4, 6-32 and 34 are currently pending in this application with claims 7-
8, 18-19, 23-25, 27-28, and 31-32 withdrawn (from a previous restriction election filed
12/27/2005) leaving claims 1-4, 6, 9, 9-17, 20-22, 26, 29, 30 and 34 pending for
examination. For response to Applicant's Remarks filed 5/1/2006 see response to
arguments below.

Claim Rejections - 35 USC § 102

The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
form the basis for the rejections under this section made in this Office action:

A person shall be entitled to a patent unless -

(b) the invention was patented or described in a printed publication in this or a foreign country or in public
use or on sale in this country, more than one year prior to the date of application for patent in the United
States.

Claims 1-4, 6, 9-13, 20-21, 26 and 29-30 rejected under 35 U.S.C. 102(b) as
being anticipated by Negre (5,643,194). Negre discloses a subcutaneous valve and
device for externally setting it.

Regarding claims 1-4, 6, 9-13, 20-21, 26 and 29-30, Negre discloses a
subcutaneous implant system comprising a fluid chamber having an inlet (6) and outlet
(7) with an internal magnet (12,13) disposed within the fluid chamber with the magnetic
elements being able to move in a rotational motion and a positional displacement
(Figures 1-2). An external magnetic device (17) is provided for setting and flow control
the implanted device through the skin (col 2, In 44-53) wherein the device is rotatable.

Application/Control Number: 10/726,066 Page 3

Art Unit: 3763

The device of Negre is capable of being (col 1 , 59-62; col 6, In 65-67 and col 7, In 1-2)
implanted and used in many intervening medical functions and is capable of being used
with a cochlear implant. The system is designed to be implanted and inherently this is
composed of various plastics (col 1 , In 59) and is inherently biocompatible to facilitate
internal implantation without rejection. There are various internal magnetic components
that are multiple cylindrical and spherical shapes (Figures 1-2).

Claim Rejections - 35 USC § 102

Claim 34 is rejected under 35 U.S.C. 102(b) as being anticipated by Loe
(3,371 ,670) or Bucalo (3,777,737). Loe discloses a fluid control bi-stable magnetic duct
valve while Bucalo discloses a device and method for reversibly interrupting fluid flow.

Regarding claim 34, Loe discloses a fluid chamber with an inlet and outlet with
an internal magnet that is capable of restricting the fluid flow (Figure 1 ) without a spring
while Bucalo also discloses a fluid chamber with an inlet and outlet with an internal
magnet that is capable of restricting the fluid flow without a spring (Figures 12-13).

Claim Rejections - 35 USC § 103

The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
obviousness rejections set forth in this Office action:

(a) A patent may not be obtained though the invention is not identically disclosed or described as set
forth in section 102 of this title, if the differences between the subject matter sought to be patented and
the prior art are such that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said subject matter pertains.
Patentability shall not be negatived by the manner in which the invention was made.

The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148

USPQ 459 (1966), that are applied for establishing a background for determining

obviousness under 35 U.S.C. 103(a) are summarized as follows:

Application/Control Number: 10/726,066 Page 4

Art Unit: 3763

1 . Determining the scope and contents of the prior art.

2. Ascertaining the differences between the prior art and the claims at issue.

3. Resolving the level of ordinary skill in the pertinent art.

4. Considering objective evidence present in the application indicating
obviousness or nonobviousness.

Claims 21-22 are rejected under 35 U.S.C. 103(a) as being unpatentable over

Negre in view of Rehder et al (USPUbN 2002/01 08623). Negre meets the claim

limitation as described above but fails to include an external indicator including a

compass.

However, Rehder discloses an external indicator for use with an implantable
magnetically actuated device (Figure 2).

At the time of the invention, it would have been obvious to incorporate the
external indicator of Rehder into the invention of Negre. The motivation would have
been in order to locate the device for ease of removal if the device is defective and
needs to be replaced (see summary of Rehder).

The references are analogous in the art and with the instant invention; therefore,
a combination is proper. Therefore, one skilled in the art would have combined the
teachings in the references in light of the disclosure of Rehder.

Claim Rejections - 35 USC § 103

Claims 14-17 are rejected under 35 U.S.C 103(a) as being unpatentable over
Negre. Negre meets the claim limitations as described above except for various
biocompatible coatings.

Regarding claims 14-17, it would have been obvious to one having ordinary skill
in the art at the time the invention was made to coat the various internal parts to

Application/Control Number: 10/726,066 Page 5

Art Unit: 3763

facilitate biocompatibility, since it has been held to be within the general skill of a worker
in the art to select a known material on the basis of its suitability for the intended use as
(such as internal implantation, of which silicone is well-known biocompatible material) a
matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA
1960).

Response to Arguments

Applicant's arguments with respect to claims 1-4, 6, 9-17, 20-22, 26 and 29-30
regarding the Prosl et al. (4,541,429) and Marion (4,443,214) references have been
considered but are moot in view of the new ground(s) of rejection necessitated by
Applicant's amendments to independent claims 1 and 29.

Conclusion

Applicant's amendment necessitated the new ground(s) of rejection presented in
this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
CFR 1.136(a).

A shortened statutory period for reply to this final action is set to expire THREE
MONTHS from the mailing date of this action. In the event a first reply is filed within
TWO MONTHS of the mailing date of this final action and the advisory action is not
mailed until after the end of the THREE-MONTH shortened statutory period, then the
shortened statutory period will expire on the date the advisory action is mailed, and any
extension fee pursuant to 37 CFR 1 .136(a) will be calculated from the mailing date of

Application/Control Number: 10/726,066

Page 6

Art Unit: 3763

the advisory action. In no event, however, will the statutory period for reply expire later
than SIX MONTHS from the date of this final action.

Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Christopher D. Koharski whose telephone number is
571-272-7230. The examiner can normally be reached on 7:30am to 4:00pm EST.

If attempts to reach the examiner by telephone are unsuccessful, the examiner's
supervisor, Nick Lucchesi can be reached on 571-272-4977. The fax phone number for
the organization where this application or proceeding is assigned is 571-273-8300.

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Status information for unpublished applications is available through Private PAIR only.
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system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.

Christopher D. Koharski

AU 3763

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